FDA.reportPublic FDA data

Aplicare Povidone-Iodine Paint

Manufacturer
Aplicare, Inc.
Effective date
2017-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:50:01

Label at a glance#

ProductAplicare Povidone-Iodine Paint
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

use sponge sticks to prep desired area

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

antiseptic skin preparation

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if allergic to iodine
  • in the eyes

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep wounds
  • puncture wounds
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

SPL UNCLASSIFIED SECTION

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

SPL UNCLASSIFIED SECTION

Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

STORAGE AND HANDLING SECTION

Avoid excessive heat. Store at room temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

use sponge sticks to prep desired area

Other information

SPL UNCLASSIFIED SECTION

  • 1% titratable iodine
  • for single use only
  • not made with natural rubber latex
  • for hospital or professional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

OTC - QUESTIONS SECTION

For questions, comments, or to report serious side effects:

800-760-3236

Monday-Friday 8:30 a.m.-5:00 p.m. EST

PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52380-4011-2

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

TWO POVIDONE-IODINE PAINT
SPONGE STICKS

ANTISEPTIC
Non-Sterile Solution

Two 8-inch Sponge Sticks Saturated with
Povidone-Iodine USP, 1% Available Iodine

Reorder No. F-2011

PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet
PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN1
312564povidone-iodine 100 MG/ML Topical SolutionSCD1
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52380-4011-22020-01-31C16284748780-19d75b9d1-05fa-f424-e053-dadaa90a57ceAplicare Povidone-Iodine Paint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-4011-2Aplicare Povidone-Iodine Paint2 mL in 1 PACKETSOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-4011APLICARE POVIDONE-IODINE PAINT (POVIDONE-IODINE) SOLUTION [APLICARE, INC.]1Legacy NDC, 1 package rows20170602_25319273-188a-4656-a867-c49e57919b27.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-4011-2EA - Each52380-40114a53df9e-037b-4684-8298-4ed545cb342212017-07-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-401152380-4011-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8f2375fd-e829-4ee3-b70d-2ad577cd6da025319273-188a-4656-a867-c49e57919b272017-06-01WarningsExact identifier
spl id: 8f2375fd-e829-4ee3-b70d-2ad577cd6da0
spl set id: 25319273-188a-4656-a867-c49e57919b27

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.